MedPath

Multilevel Intervention for Precision Oncology

Not Applicable
Not yet recruiting
Conditions
Advanced Cancers of the Prostate
Cancers of the Lung
Registration Number
NCT06825715
Lead Sponsor
VA Office of Research and Development
Brief Summary

The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

Detailed Description

Background: Precision oncology (PO), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. Extensive study, however, documents that up to 50% of patients in the VA, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended PO.

Methodology: Building on the investigators' previous analyses, and the Theoretical Domains Framework, the investigators designed a mixed-methods type I hybrid effectiveness-implementation study of a multilevel intervention (MLI) to improve the use of PO. The MLI will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). The patient intervention is a 5-minute educational module accessible by QR code. The provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. The facility level intervention is a previously piloted integration of PO ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. The primary efficacy outcome is the rate of molecular testing/eligible veterans. Validated survey measures will be used for stakeholder engagement. The process evaluation employs a mixed methods approach based in the RE-AIM framework, which includes quantitative analyses of collected data, and interviews of patients and providers. The statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
2653
Inclusion Criteria
  • Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic
Exclusion Criteria
  • Cancer that did not originate in the prostate or the lung

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Use of molecular testing3 years

Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing

Secondary Outcome Measures
NameTimeMethod
Use of targeted therapy3 years

Proportion of patients with actionable molecular alterations who have targeted therapy.

Trial Locations

Locations (1)

VA NY Harbor Healthcare System, New York, NY

🇺🇸

New York, New York, United States

VA NY Harbor Healthcare System, New York, NY
🇺🇸New York, New York, United States
Antoinette Vo, BA MA
Contact
212-686-7500
antoinette.vo@va.gov
Daniel J Becker, MD
Principal Investigator
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